Home | 2-PAGE SUMMATION ON STATINS | Understanding Atherosclerosis & its MI Link--jk | understanding heart attack | lipids, lipoproteins, the basics | ABOUT Cholesterol | Tables of Risk Factors plus STATS | Niacin prevents MI 25% | Statins, inflammation & atherogenesis--their failure | inflammation, obesity and atherosclerosis | Risk Factors Athereosclerosis | High Cholesterol and treatments | STATINS, lowering cholesterol doesn't prolong life | MMP role in atherogenesis and statins | COX-2 Suppression and statins | High HDL not Prophylactic | Other Markers for Cardiovascular Disease | $70,000 standard heart treatment per year following a MI | Why improving cholesterol profile with statins has little effect | Statins side effects | Statins over prescribed | Recommendation for your heart | New Major Study Pans Statins | STATIN COMBO STUDY, NO BENEFITS | C-Reactive Protein and Statins | Ozone & cholesterol combine to cause heart disease | Calcium score and coronary disease--a review | Serious cognitive impairment from bypass operation, Scientific American | ARRHYTHMIA, sudden early death and prevention for relatives | STEM CELLS GROW HEART MUSCLE | BYPASS & STENTS over sold

Statins a 3 Page Critical Review 12/23/15 It is essential for you to understand how pharma (pharmaceutical industry) distorts, and controls medical information, and guidelines, thus the practice of medicine--see Market Science and Misinformation side effects. Marketing pitch for the statins is based on high Total Cholesterol (TC) and LDL causing heart attacks, strokes and, CardioVascular Disease (CVD); but CVD is caused by bacterial and viruses within the artery wall (tunica media) and the immune system’s response, thus lowering cholesterol doesn’t work--see Cholesterol Myth. LDL has 2 functions, one is to as needed actively transport to cells cholesterol and triglycerides (fat), the other is its immune-system function: it neutralizes (binds) toxins produced by pathogens—see. LDL in the artery walls is a sign of pathogens causing inflammation. Thus the presences of LDL, cholesterol, and triglycerides in the plaque of artery walls is because of LDL’s immune function. LDL is like a fireman at a fire, a response. Lowering LDL promotes damage by toxins. Yes statins lower LDL and cholesterol, but that doesn’t benefit the patient. The doggy clinical trials ran by pharma for marketing purposes fail to show significant reduction in deaths, so pharma markets statins based on lowering cholesterol and rigs the clinical guidelines. Marketing and influence trumps medical science. The best-selling drug of all times is atorvastatin, marketed as Lipitor by Pfizer (US sales $12.4 billion in 2008, and world-wide total sales of $131 billion by 2007). With 50% of the men and 36% of the women age 65 to 74 taking statins (CDC/NCHS, Health, US, 2010); their human costs is incredible; made worse because better alternatives are shown harmful by pharma’s tobacco science. The cholesterol myth and effective prevention get little space in the corp. media.—watch YouTube documentaries. Statins discovery and approval casts doubts. In the early 1970s an extract from a fungus was shown reduce serum cholesterol, but the Japanese research stopped because of animal toxicity & cancer. Using a similar extract Merck in 1978 developed Mevacor (lavostatin). This “’Statin produced significant toxicity at high doses in a variety of animal species” (ibid 520). Animal studies showed it caused cancer (given the 20-year latency in humans, still a grave concern). Merck tested low-dose Mevacor for homozygous familial hypercholesterolemia. The FDA gave approval for this rare condition. Once approved--as is the norm--the population base was expanded based on “marketing science”. Because statins lower TC 30%, they were pushed as the only effective treatment for CVD. But weak epidemiological association of elevated TC with CVD doesn’t demonstrate cause. With in-house studies Merck and the manufacturers of the 9 me-too statins sold the world on “safe-and-effective”. In Braunwald, Heart Disease, 8th Ed. P 2286: “safe, effective, and well-tolerated pharmacologic agents that have greatly expanded the therapeutic armamentarium available to the physician to treat disorders of lipid metabolism.” But in Braunwald, p 1085 table, 3 of 4 listed studies didn’t support effective. Merck’s JUPITER Study, 2008, is used to push primary prevention, but has major internal inconsistency: the cooked results “do not support primary prevent of CVD”. Moreover, “statin therapy and top athletics seem to be almost incompatible,”73% dropped out. Statins don’t extend life and their side effects are grossly under-reported. Because statins don’t treat the causes of CVD, they are ineffective; thus there is a chorus of marginalized critics. 19 NEGATIVE EFFECTS: One, ED, it lowers testosterone , and nitrous oxide thus causes ED; a similar effect upon women for the steroids are synthesized from cholesterol. Two, COX-2 inhibitor, just like Vioxx, which increased heart attacks (MIs) over 300% . The American Heart Association warns: “accumulated evidence that non-steroidal, anti-inflammatory drugs [COX inhibitors], with the exception of aspirin, increase risk for heart attack and stroke”--promote atherogenesis. Three, blocks production of Q10, which enters LDL and inhibits oxidative damage that causes atherogenesis, and. Four, Plaque instability: “Vulnerability of plaques to rup¬ture and thrombosis is of greater clinical relevance than the degree of stenosis they cause” (Corti et al., 2003). “Statins affect plaque stability in a variety of ways. The meta-loproteinases degrade extra-cellular matrix components and thus “weaken the fibrous cap and destabilize the lesions” -- Goodman and Gilman pharmacology, 11th Ed, p 950. Rupture of plaque causes over 80% of MIs. Statins inhibit secretion MMP-1, 3, & 9 from SMC, and microphages make plaque less stable. Five, reduction in ATP: Q10 is needed for the conversion of APD to ATP (adenosine-5-triphosphate), the source of energy for muscles contraction. “ATP is often called the ‘molecular unit of currency’ of intracellular energy transfer including muscle contraction and for chemical reactions. ATP transports chemical energy within cells for metabolism”--Wikipedia. A reduction of 40% in CoQ10 is accepted. Six, The heart muscle under stress needs more ATP, not less. This is why pharma excludes the elderly and those with coronary heart failure (CHF) from trials. Thus, “the mean age of ME/CFS patients dying from CHF are 2.5 years younger than the control group.” CHF death rate has tripled since 1989. In a review of statins on depletion of Q10 concludes: “As the potency of statin drugs increases and as the target LDL cholesterol level decreases, the severity of Q10 depletion increases and heart-muscle function declines. This tragic scenario may very well be prevented by using supplemental Q10 with all HMG CoA reductase inhibitors [statins]” and, and. Thus “Lower cholesterol, poorer outcome in CHF patients.” Pharma ignores Q10 side effect. Seven, All Statins inhibit the rate controlling enzyme HMGCR of the mevalonate pathway. “This pathway generates a range of other products in addition to cholesterol, including coenzyme Q10, heme-A, [dolichol], the production of dimethylallyl prophosphate (DMAP), & isopentenyl pyrophosphate (IPP), which serve as the basis for the biosynthesis of molecules used in processes as diverse as terpenoid synthesis, protein prenylation and isoprenylated proteins which have pivotal roles in cell biology and human physiology and potential relevance to benefits as well as risks of statins. Drugs, such as the statins, stop the production of mevalonate by inhibiting HMG-CoA reductase” Wiki. “The Mevalonate pathway is important for, cell membrane maintenance, hormones, protein anchoring, and N-glycosylation. It is also a part of steroid biosynthesis” Wiki. “Dolichols are isoprenoids synthesized from mevalonate. They are vital to the process of Glycoprotein formation in the endoplasmic reticulum of cells. In this capacity it is critical to the formation of the Glycoproteins involved in neuro-peptides, cell identification, cell messaging and Immune defense. Reduced bioavailability of dolichols can affect every cellular process in the body” Wiki. And this is only a partial list. Eight, Cholesterol is essential for life. “It is the precursor for the biosynthesis of steroid hormones, bile acids, vitamin D, and is an essential component of cell membranes for proper permeability. Effects include pancreatic and hepatic dysfunction, ED, diabetes , muscle weakness and myopathy (muscle disease). The myelin is a cholesterol base coating around nerve cells ” (Wiki). Nine, Cognitive, the reduction Q10 & cholesterol for the myelin sheath causes cognitive decline--especially in the elderly where it often leads to an incorrect diagnosis of Alzheimer’s disease and of neuropathy. Ten, Causes Parkinson’s and Alzheimer’s diseases. These conditions are associated with low level of cholesterol—at Uffe p 56. Eleven Causes cancer a confirmation of earlier animal studies—summary of cancers, and. Twelve Stimulates atherosclerosis and heart disease by blocking the vital CoQ10, heme A, vitamin K2 (the cofactor for matrix Gla-protein activation) and biosynthesis of selenium containing proteins, one of which is vital glutathione peroxidase—at 2015. This article states that “statins stimulate atherosclerosis and heart failure”, and then provides the mechanisms. Thirteen Causes Interstitial lung disease is similar to emphysema in that it is a progressive condition that affects alveolar epithelium and other tissues. Of FDA reported side effects, it is 1/40th. Fourteen, Causes cancer in animal studies, and thus in humans, at. Fifteen, Polyneuropathy, damage affecting peripheral nerves, features weakness, numbness, pain, etc. is 26 times more common after 2 years on statins compared to general matched population—at. Sixteen Side effects account for the poor compliance in the elderly (75% stop within 2 years). Poor compliance also occurs with elite athletes (see 1st pg). Seventeen treats the wrong cause, cholesterol doesn’t cause ischemic events or atherosclerosis but rather infective agents (and) living in the tunica intima; thus statins are ineffective. Three out of 4 major studies of secondary prevention (ALL-HAT, ASCOT, & PROSPER) failed to find life extension from statins (Table 42-78, Braunwald’s Supra, p 1085). This table stands in opposition to the “safe & effective” claim (p 2286), which is pharma’s mantra, a mantra supported by their marketing studies and guidelines. Junk science is the norm (p 3) on TNT trial. Eighteen, Primary prevention of high risk no benefit huge meta-study found, in JAMA. Nineteen, drug interaction with serious side effects are common, considering that over half of senior in their 6th decade have taken statins, and seniors average age 72 average 6 drugs according to a hospital emergency admission study (polypharmacy). THREE POSITIVE EFFECTS: 1) Anti-inflammatory effect: but because of effect upon prostaglandins statins like the NSAIDs doesn’t inhibit atherogenesis inflammatory process—see Vioxx, and. 2) Statin reduces the risk for thrombosis by affecting clotting, just like aspirin. But rather than promote the sales of over-the-counter NSAID, pharma pitches lower TC. 3) For the rare familial hyperlipidemia extends life modestly at best—Prof. Ravnskov, Ignore the Awkward, chap. 3. On statins: Since “cholesterol synthesis occurs mostly at night” (Wiki), TC should be treated at night with short half-life & low dose: Zocor 2 hr. Mevacor 1.4 hr. Pravachol 1.75 hr. and niacin 35 min--avoid Lipitor 14 hr., Crestor 19 hr. Sorting it out, RECOMMENDATIONS: Atherogenesis is caused pathogens within the artery walls. This initiates an inflammatory immune response by macrophages. LDL which has an immune response is actively transported into the artery walls where it contents cholesterol from part of the resultant plaque. Because of this transport process, lowering LDL doesn’t affect the formation of plaque, thus statins don’t stop plaque formation or remove it from within artery walls (see illustration). The 32% drop in deaths from heart attacks and strokes (1960 to 1992) occurred prior to statins. With statins’ wide use, mortality rate has remained constant. Mevacor was approved in 1987 with only 60,000 taking it by 1990. Reduced death rate was from less cigarettes and better treatment. Statins reduce quality of life for the elderly: a large Canadian study had 75% dropout by 2 years, and 80% in a NJ study. Very common and under reported side effects are: fatigue, muscle weakness & cramps, mental confusion, pancreatic and liver dysfunction, diabetes, indigestion, cognitive decline, ED, & lower libido, especially for the elderly. Lowering TC with statins doesn’t affect the young unstable plaque that cause 85% MIs because pathogens are the cause of the plaque formation. . What to do: Don’t take a statin because they do not reduce mortality; they aren’t worth their side effects & expense. Lifestyle changes of low carbohydrate-sugar diet lowers damage to endothelial cells on the artery walls. Damage is caused mainly by glycation by fructose (7.5 times the rate of glucose). Avoid carbon monoxide (cigarettes main source) which exacerbates the damage. Endothelial cells block the migration of pathogens. Saturated and monounsaturated fats are the best source of energy. Everyone should take the antioxidants ascorbic acid and Q10, prevent oxidative damage. Take 325 mg aspirin with meals for its anti-inflammatory effect that prevents CVD; and aspirin prevents blood clots thus lowering ischemic events, etc5. Low dose aspirin is ineffective because of tolerance after 1 year. Take the natural estrogen (estradiol) & progesterone at menopause. Estrogen lowers risk of CVD 50%, osteoporosis and much more. For elderly men testosterone lowers risk & increases survival from an MI. Pharma attacks hormones & aspirin because they work. Read Marking Science, be skeptical of medical “wisdom.” If you still want to lower TC then take 250 mg slow release niacin or inositol hexanicotinate at night, when it is effective. Insulin produced following meals blocks the lipid lowering effect of niacin inositol & statins. High dose during the day is a pharma ploy to reduce the use of niacin. JK has exercised vigorously since 1975; 325 mg twice daily aspirin since 1992; testosterone high dose 2003; low-sugar low carb diet 2014, 300 mg CoQ10 2012, and vitamin C 1000 mg (as calcium ascorbate) 2014. Results: JK is in 7th decade, excellent muscle tone and strength, no joint pain, blood pressure averages 125/75, BMI 23, and total cholesterol 165. Pharma has turned hypertension, and cholesterol into medical conditions, and watch documentaries on YouTube.


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Statins and cholesterol:  Cardiovascular disease (CVD) results from reactive chemical damage to LDL and VDL (the bad cholesterols) that stimulates an inflammatory response in macrophages that engulf the damaged LDL.  This result in the formation of foam cells (dead macrophages), which constitute most of plaque.  Macrophages are a type of white blood cell that scavenges damage cells and promote healing.  A lower level of cholesterol doesn’t prevent reactive chemicals from damaging LDL.  The main cause of damage LDL is glycation (a simple sugar attaching to LDL) and reactive chemicals produced from the metabolism of glucose and fructose.  Thus low carb low sugar diet along with regular strenuous exercise is the first line of prevention.  Carbon monoxide from incomplete combustion (especially cigarettes) is another important cause for damaged LDL.  Cholesterol and triglycerides are essential for life.  The liver produces cholesterol and triglycerides (a form of fat) for transport within LDL for blood transport to cells which have LDL receptors.  More packages of LDL are produced to replace the damage LDL, thus damage causes higher level of LDL and its contents.  Lowering cholesterol and triglycerides is a bad idea, for this doesn’t treat the cause of CVD , reactive chemicals and the immune response.  Thus statins don’t protect against coronary artery disease and its deadly consequences.  Several large earlier clinical trials have failed to find significant health benefits from statins—though of course there are later marketing studies that produce positive results.  Statins side effects (especially its negative effects upon cognitive function, sexual activity, and physical energy) make them not worth taking.  Pharma has done marketing (junk)studies to show that statins are safe and effective.  Pharma’s use of continuing education classes taught by their opinion leader to promote sales of statins, hypertension drugs, etc.    In these classes thy say little about side effects, the negative early studies as to prevention of death, storke and heart attacks, or that those with congestive heart failure and the frail die at a higher rate on statins.  The critics lack an effective forum to affect medical practice.   For prevention of CVD the best choices is a low sugar and carb diet, exercise. Strong evidence support taking  CoQ10 300 mg, which prevents oxidative damage to LDL, aspirin 325 with meals for its anti-inflammatory effect, post-menopause women should take the natural estradiol 2 mg (the only effective natural estrogen) plus 100 mg progesterone, and for elderly men topical testosterone 100 mg in a topical lotion.  These hormones and drugs lower the risk for CVD, metabolic syndrome, and the resultant much higher rates for heart attacks and strokes, and have other healthful effects.   The best source for hormones is a compounding pharmacy.  Pharma uses marketing (tobacco) science to discourage the use of these off-patent products.

TERMS:  Primary prevention for those with high cholesterol only.  Secondary prevention for those with pre-existing cardiovascular disease (CV).  Opinion Leader: an authority in a specialty who receives substantial income from pharma.  Cardiovascular Disease (CVD) any disease, whether congenital or acquired, of the heart and blood vessels.  Cholesterol Profile (TC) the lab report listing the various components of cholesterol.  Coronary Heart Disease (CHD) atherosclerotic arterial deposits (atherosclerosis).   Congestive Heart Failure (CHF)/ heart failure (HF) occurs when the heart muscle is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation.  Myocardial Infraction (MI) a heart attack.  HMG-CoA reductase inhibitors (statins).

TERMS:  Primary prevention for those with high cholesterol only.  Secondary prevention for those with pre-existing cardiovascular disease (CV).  Thought Leader: an authority in a specialty who receives substantial income from PhARMA.  Cardiovascular Disease (CVD) any disease, whether congenital or acquired, of the heart and blood vessels.  Cholesterol Profile (CP) the lab report listing the various components of cholesterol.  Coronary Heart Disease (CHD) atherosclerotic arterial deposits (atherosclerosis).   Congestive Heart Failure (CHF)/ heart failure (HF) occurs when the heart muscle is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation.  Myocardial Infraction (MI) a heart attack.  HMG-CoA reductase inhibitors (statins).

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Animal studies are a very good indicator for potential side effects in humans:  The original studies are done on animals to find out if a drug is effective and safe.  Unfortunately when PhARMA funded they own the results and as part of normal business do not published unfavorable results.  However, since such studies are fairly inexpensive, a number of them of animal studies are part of graduate work supervised by a professor, and are published.  Others, like this review are written by the manufacturer, in this case Merck.  The article mentions the side effects and then concludes that they don’t occur in “human therapeutic doses.”  A large body of evidence contradicts this rosy conclusion.  It is very disappointing that the top tier journal Nature published this article, which is a sales pitch for Lipitor, dressed up as a review of the research. (see the published summation below to dispel doubt)  For example the effects upon testosterone and CoQ10 are not mentioned—though there is significant literature on their suppression by Lipitor and other statins.   

Below is an example of marketing science.  It is a review of the research on Mevicor (Lovastatin) by Merck (hardly unbiased in their dismissal of the relevance of animal studies).  Worth reading as to risk factors since animal studies have a high carryover to humans.   Tolbert left out the “c” word cancer, for which this side effect in animals is be repeatedly brought up.  Since most cancers have a 20-year lag time (such as cigarettes) from exposure, short-term clinical trials will not expose this risk.  It took for example 30 years for cancer to be associated with DES, a synthetic estrogen, and 50 years for MPA (methoxyprogesterone, which is still on the market). 


SIDE EFFECTS ANIMALS:  “Statins produce significant toxicity at high doses in a variety of animal species. These effects include increases in hepatic transaminases, atypical focal hyperplasia of the liver, squamous epithelial hyperplasia [ORGAN ENLARGEMENT] of the rat fore-stomach (an organ not present in man), cataracts, vascular lesions in the central nervous system (CNS), skeletal muscle toxicity, testicular degeneration and, although the statins are clearly not genotoxic, tumours of the liver and other sites (details can be found in the product circulars of the individual statins). It has been shown, where it has been practical to conduct the experiment, that these effects can be prevented by administering mevalonate 29,30, the product of the reaction catalysed by HMG-CoA reductase.  This indicates that these toxic effects are mostly, if not entirely, attributable to extreme inhibition of the enzyme at high doses 29.  So Merck, and the regulatory agencies considering the marketing application submitted by Merck, were faced with a wide range of animal toxicological effects, as well as the history of compactin and the known central role of the cholesterol biosynthesis pathway in many physiological processes, including the production of steroids and cell membranes.  [Since the toxicity of the very similar in structure compactin, whose toxicity in animal studies resulted from it not being tested clinically, that the same occurred for Lovastin, but Merck went forward. Compactin was withdrawn from the market for ]   … Fortunately, except for rare cases of myopathy and marked but asymptomatic increases in hepatic transaminases, none of the adverse effects found in animals occur at human therapeutic doses.” Nature Reviews Drug Discovery 2, 517-526 (July 2003) | doi:10.1038/nrd1112

Author’s affiliations: A. Tolbert, Merck Research Laboratories, Rahway, New Jersey 07065, USA.

Those who have a financial interest in the outcome manipulate the results, Major study finds that all 37 journal articles positive effects over stated; the average was 32%. Statins cause erectile dysfunction, cognitive imparement, and cancer.  

Lipitor (2011) lifetime sales $131 billion, tops all drugs.  Plavix at $60 billion is second.



52% short term


LA Times, Health section, July 21, 2008  --  excerpts

Vytorin, the combination drug (simvastatin (better known by its commercial name Zocor) and ezetimibe--known as Zetia) prescribed to lower cholesterol, sustained another blow today, when the author of a major clinical trial announced that the medication had failed to drive down hospitalization and death due to heart failure in patients with narrowing of the aortic valve. In the process, researchers in Norway detected a significant blip in cancers in the 1,800 subjects they followed

Today's findings suggested something more ominous: the incidence of cancer -- and of dying of cancer -- was significantly higher in the patients taking Vytorin. Altogether, 67 patients on placebo developed cancer during the trial. Among subjects on Vytorin, 102 developed cancers of various kinds.*  This is the second adverse press—the first being in March 08, when the ENHANCE trial found that Vytorin fared no better than a placebo at reducing plaque buildup on the walls of patients' arteries.* *

Comments by jk

Simvastatin (Zocor) is off patent.  Thus in a scramble for profits a combination drug (on patent) was introduced.  Direct to consumer market cost $155 in 07—mainly TV ads. 

*  The pressing issue is that since the development  of Statins, the very first animal studies in the 60s it has been known that Statins increase the incidents of cancer.  However, nearly all studies done thereafter have not included cancer. 

*  Several studies have failed to find a reduction in the build of plaque, even thought the statins including Zocor, reduce LDL and cholesterol.  Few studies include the principle reason for taking a statin, namely a reduction in the death rate.  Claims for such reduction probably entail a failure to control the contravening variable, aspirin usage.  Given a pile of evidence, including the very mechanism of plaque formation, which involves inflammation process, I must conclude that the use of statins is highly suspect.  Given the harm done including cognitive impairment, weakness, and cancer, if my skepticism is born out, the harm done by statins as a course of treatment will far surpass that of VIOXX which killed over 200,000 people world wide by accelerating atherosclerosis.